Russian Registry of Patients With nAMD

NCT04935411 | Terminated

• 1 other identifier: CRTH258ARU01
• Study Type: observational
• Target: 2,665
• Locations: 1 country
• Sites: 1

Brief Summary

A three-year, non-randomized, observational, multicenter prospective nAMD study - patient registry.

Conditions

Neovascular Age-Related Macular Degeneration

Keywords

Neovascular Age-Related Macular Degeneration; nAMD

Outcome Measures

Primary Outcomes (12)

• Number of patients by gender

  Number of patients by gender to be provided

  Baseline

• Age at the diagnosis

  Age at the diagnosis to be provided

  Baseline

• Percentage of patients with comorbidities and concomitant procedures and medications

  Percentage of patients with systemic and ophthalmic comorbidities and percentage of patients with concomitant procedures and medications to be provided

  Baseline

• Patients with unilateral or bilateral disease

  Percentage of patients with unilateral or bilateral disease

  Baseline

• Time from diagnosis to entry to the registry

  Mean time from diagnosis to entry to the registry to be presented

  Baseline

• Social Characteristics (Working and Disability status)

  Working status (number of patients that work/does not work, with age-related pension, disability pension). Disability status (number of patients established/not established, removed, disability group, whether AMD is the main reason for disability)

  Baseline

• Visual acuity

  Changes in visual acuity assessed by Sivcev-Golovin's table (The table consists of two parts with 12 rows each, representing visual acuity values between 0.1 and 2.0.) or Snellen equivalent

  Baseline, up to 2 years

• Presence of edema and/or neuroepithelium detachment and/or pigment epithelium detachment

  Presence of edema and/or neuroepithelium detachment and/or pigment epithelium detachment. (yes/no)

  Baseline, Up to 2 years

• Presence of macular atrophy

  Presence of macular atrophy (with or without foveal involvement) (yes/no)

  Baseline, Up to 2 years

• Central retinal thickness

  Central retinal thickness to be measured with OCT (optical coherent tomography)

  Baseline, Up to 2 years

• Fluid type

  Type of the fluid assessed by optical coherence tomography and defined as follows: intraretinal fluid (IRF), subretinal fluid (SRF), fluid under repinal pigment epithelium (sub-RPE)

  Baseline, Up to 2 years

• Indication for intravitreal anti-VEGF therapy

  Indication for intravitreal anti-VEGF therapy to be collected

  Baseline, Up to 2 years

Secondary Outcomes (9)

• Type of prescribed therapy

  Up to 2 years

• Percentage of patients with prescription of anti-VEGF drugs

  Up to 2 years

• Time from diagnosis to the therapy initiation

  Up to 2 years

• Time from diagnosis to anti-VEGF injection

  Up to 2 years

• Number of visits per year

  Up to 2 years

Study Arms (1)

nAMD patients

patients diagnosed with Neovascular Age-Related Macular Degeneration

Other: nAMD

Interventions

nAMD OTHER

patients diagnosed with Neovascular Age-Related Macular Degeneration

nAMD patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Neovascular Age-Related Macular Degeneration in Russia

You may qualify if:

• Age \> to 18 years
• Male or female patients diagnosed with nAMD (with or without previous treatment for nAMD including but not limited to PDT, laser coagulation, vitamins, retinolamine, emoxipine, anti-VEGF therapy or any surgery for nAMD).
• Willing and able to provide informed written consent personally or by legal proxy

You may not qualify if:

• The patient is simultaneously participating in a different nAMD therapy study.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Investigative Site

Novosibirsk, 630087, Russia

Location

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 23, 2021
• Study Start: December 20, 2020
• Primary Completion: December 5, 2022
• Study Completion: December 5, 2022
• Last Updated: August 7, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)